Food and Drug Administration News

Date Posted
Article Title
10/9/2013
Cancer Drug Nexavar Tied to Pancreas Damage in 2 Patients

Pancreas shrank by up to one-third in case studies following long-term use

10/9/2013
Adempas Approved to Treat Pulmonary Hypertension

New drug works to ease high blood pressure in lung arteries

10/4/2013
FDA OKs Drug to Treat Hot Flashes in Menopausal Women

Clinical trials also showed some protection against bone loss; blood clots are a risk

10/2/2013
Medicare, Medicaid To Keep Running Despite U.S. Government Shutdown

But other programs, such as disease surveillance, food and drug inspections, could be curtailed, according to contingency plans

10/1/2013
Statins May Not Harm Memory, Thinking After All

But even with new study, jury's still out on safety of cholesterol-lowering drugs

10/1/2013
Brintellix Approved for Major Depressive Disorder

Depression can interfere with everyday life

9/30/2013
Medicare, Medicaid Would Keep Running If U.S. Government Shuts Down

But other programs, such as disease surveillance, food and drug inspections, could be curtailed, according to contingency plans

9/30/2013
Perjeta Approved for Early Stage Breast Cancer

Previously used for advanced disease

9/30/2013
FDA Approves First 'Pre-Surgical' Drug for Breast Cancer

Perjeta, which seems to shrink early-stage tumors, can now be used before surgery

9/23/2013
FDA Sets Rules for Smartphone Medical Apps

Agency will only regulate those that turn phones into medical devices

9/20/2013
FDA Launches System to Label Medical Devices

Goal is to improve patient safety, identify items for recall and prevent counterfeiting

9/20/2013
U.S. Funds New Tobacco Regulation Research Centers

14 centers across the country awarded $53 million at start

9/19/2013
FDA Airs Plan to Strengthen Rules for Imported Foods

50 percent of fresh fruit and 20 percent of fresh vegetables from abroad, agency says

9/16/2013
First Generic Version of Xeloda Approved

To treat colorectal or breast cancers

9/16/2013
New Device Approved for Enlarged Prostate

Helps relieve blocked urine flow

9/12/2013
Botox Approved as Temporary Treatment for Crow's Feet

Already approved for cosmetic 'frown lines'

9/11/2013
FDA Approves Botox for Crow's Feet

However, cosmetic improvement is only temporary

9/10/2013
FDA Announces New Safety Measures for Narcotic Painkillers

Label warnings designed to limit use of extended-release, long-acting drugs like Oxycontin

9/10/2013
Novel Drug Shows Promise for Early Stage Breast Cancer

Perjeta might gain quick FDA approval

9/5/2013
Teens' Use of E-Cigarettes Doubles in a Year: CDC

Health officials worry the devices may cause more children to become addicted to tobacco products

9/3/2013
New Diabetes Drug Seems Safe for Heart, Study Finds

Onglyza study reflects new cautious approach to oversight of diabetes medicines, experts say

8/27/2013
Mexico Farm Tied to Stomach Bug Back in Operation

U.S. health officials still haven't identified source of more than 600 infections

8/22/2013
Hyperbaric Oxygen Chambers Aren't Cure-Alls, FDA Warns

Despite hype, treatment doesn't help for cancer or many other ills, and can have serious side effects

8/22/2013
Cases Reported in Stomach Bug Outbreak Top 600

Latest CDC statistics show 601 illnesses across 22 states, 40 people hospitalized

8/22/2013
New Device IDs Disease-Causing Germs

Spectrometer can identify 193 yeast and bacteria

8/19/2013
More Cases Reported in Stomach Bug Outbreak

Latest CDC statistics show 586 illnesses across 20 states, 36 people hospitalized

8/19/2013
Epilepsy Drug Warnings May Slip Through Cracks

1 in 5 neurologists unaware of updated safety risks identified by FDA, survey finds

8/16/2013
Cases in Stomach Bug Outbreak Continue to Climb

Latest CDC statistics show 576 illnesses reported in 19 states, 36 people hospitalized

8/14/2013
More Drugs Show Promise in Fighting Hepatitis C

Faldaprevir and deleobuvir are part of effort to develop treatments that avoid harsh side effects

8/13/2013
New Drug Approved to Treat HIV-1

The virus that causes AIDS

8/13/2013
Company Tied to Stomach Bug Outbreak Stops Shipments to U.S.

Salad mix from Mexico has been implicated in Iowa, Nebraska cases; source of other infections is unclear

8/9/2013
Lasers in Toys Can Cause Serious Eye Damage, FDA Warns

Although sold as playthings, they emit powerful beams

8/8/2013
Rapid Test Detects HIV-1 and HIV-2 Antibodies and HIV-1 Antigen

May help doctors diagnose AIDS-causing virus earlier

8/7/2013
Food Additive Safety Often Determined by Those With Food Industry Ties: Study

Review finds strong conflict-of-interest issues in the approval process; experts call for changes

8/6/2013
First Vaccine Against 4 Flu Strains Ready to Ship

FDA has approved distribution of new seasonal influenza shot, Fluarix Quadrivalent

8/2/2013
FDA Defines 'Gluten-Free' for Food Labels

Rule will benefit millions of Americans with celiac disease

8/2/2013
FDA Warns of Rare Skin Reactions to Acetaminophen

Cases happen very seldom but can lead to hospitalization or death, new warning label is planned

7/30/2013
Diabetes Testing Strips Recalled for Potential False Readings

Batches of Nova Max Glucose Test Strips could give erroneous, overly high blood sugar readings

7/26/2013
FDA Proposes New Safety Rules for Imported Food

Announcement comes in wake of recent outbreaks of foodborne illnesses

7/26/2013
New Test Detects TB and Antibiotic Resistance

Results available in two hours

7/23/2013
FDA Sends Warnings to Makers of Illegal Diabetes Treatments

Products make false claims, could be unsafe and may delay proven therapies, agency says

7/22/2013
Plain Brown Cigarette Packs May Help Some Smokers Quit: Study

After Australia mandated such packaging in 2012, most users found cigarettes 'less satisfying'

7/21/2013
FDA Warns of Sunscreen Spray's Flammability Risk

Avoid open flames after application, agency advises

7/17/2013
New Drug May Extend Survival for Some Prostate Cancer Patients

Study found Xofigo also improved quality of life for those whose cancer had spread to the bones

7/16/2013
First Medical Device to Help Diagnose ADHD Approved

Brain monitor tracks neurological signals in children and teens

7/12/2013
Gilotrif Approved for Late-Stage Lung Cancer

Caused by certain gene mutations

7/12/2013
FDA Proposes New Limit for Arsenic in Apple Juice

Move follows release of studies last fall showing worrisome amounts of the toxin in many brands

7/12/2013
FDA Approves New Drug for Advanced Lung Cancer

Gilotrif targets a gene mutation that occurs in about 10 percent of cases

7/8/2013
Listeria Outbreak Prompts Cheese Recall

1 person dead, 4 sickened; source seems to be Wisconsin company, CDC says

7/1/2013
First Non-Hormonal Remedy Approved for Menopausal Hot Flashes

Contains active ingredient in antidepressant Paxil